World's Smallest Pacemaker, Medtronic Micra® TPS, Meets Global Clinical Trial's Safety and Effectiveness Endpoints
November 09 2015 - 3:45PM
Data Presented at
AHA and Simultaneously Published in the New England Journal of
Medicine
Demonstrate High Implant Success and Reduced
Healthcare Utilization
DUBLIN and ORLANDO - Nov. 9, 2015
- In the largest clinical data presentation ever of
transcatheter pacing patients, Medtronic plc (NYSE: MDT) today
announced that the Medtronic Micra® Transcatheter
Pacing System (TPS) was successfully implanted in nearly all
patients in the trial - 99.2 percent - and met its safety and
effectiveness endpoints with wide margins. These data, from the
Medtronic Micra® TPS Global
Clinical Trial, were presented during a late-breaking Special
Report session today at the 2015 American Heart Association
Scientific Sessions and simultaneously published in the New England Journal of Medicine.
"We are extremely pleased with the remarkably
successful implant rates and safety profile of the Micra pacemaker,
including the absence of device dislodgments. We are especially
confident in these results because the trial included patients with
serious comorbidities from 19 countries on five continents around
the world," said Dwight Reynolds, M.D., trial principal
investigator and regent's professor and chief of the Cardiovascular
Section at the University of Oklahoma Health Sciences Center. "The
Micra TPS not only met its trial endpoints, but also provided a
significant reduction in healthcare utilization due to fewer major
complications compared to conventional pacing systems, which is
particularly important in an era of value-based healthcare."
In the Micra trial, 96 percent of patients (700 of
725; six-month Kaplan-Meier estimate) experienced no major
complications, which is significantly fewer - 51 percent fewer -
major complications than seen in patients with conventional pacing
systems (hazard ratio: 0.49; 95 percent CI, 0.33 to 0.75; P=0.001).
Major complications included cardiac injuries (1.6 percent),
complications at the groin site (0.7 percent) and pacing issues
(0.3 percent). Notably, there were no (0) dislodgments, no (0)
systemic infections, and very few (0.4 percent) system revisions
(meaning extraction, repositioning or replacement). These low
complication rates were achieved despite the inclusion of high-risk
patients worldwide, including patients with chronic obstructive
pulmonary disease (COPD).
The presentation included a comparison of Micra
TPS safety performance to a pre-defined, historical control group
consisting of more than 2,500 patients from six studies of
commercially available, conventional pacing systems. Compared to
patients with conventional systems, the patients in the Micra trial
were older and had more comorbidities, yet had fewer major
complications.
Almost all patients in the trial, 98.3 percent
(292 of 297), had low and stable pacing thresholds at six months,
yielding projected average longevity for the device of more than 12
years (300 patients at six months).
In addition, the low major complication rates
experienced by Micra patients resulted in significant reductions in
healthcare utilization compared to conventional pacing systems:
Micra patients had 54 percent fewer hospitalizations (p=0.011) and
87 percent fewer system revisions (p<0.001) than observed in the
historical control group.
At less than one-tenth the size of traditional
pacemakers, the Micra TPS is the world's smallest pacemaker yet
provides the most advanced pacing technology available. It is
cosmetically invisible and small enough to be delivered with
minimally invasive techniques through a catheter, and implanted
directly into the heart.
Comparable in size to a large vitamin, the Micra
TPS does not require the use of wires, known as "leads," to deliver
pacing therapy; rather, its flexible tines attach to the interior
of the right ventricle. The tines can be disengaged during the
implant process without causing trauma to the cardiac tissue,
allowing the device to be repositioned during implant and retrieved
if needed. Micra TPS also is the first transcatheter pacing system
to be awarded CE (Conformité Européenne) Mark for 1.5T and 3T full
body MRI scanning, providing patients with access to the most
advanced imaging diagnostic procedures.
"This is an exciting time for patients who need
pacing therapy, as the Micra technology delivered substantial value
in the trial through a less invasive procedure with fewer
complications, compared to conventional devices," said Brian Urke,
vice president and general manager of the Cardiac Rhythm and Heart
Failure's Brady business, which is part of the Cardiac and Vascular
Group at Medtronic. "We anticipate this excellent clinical
performance will help reduce healthcare costs and provide economic
benefit as well."
In the United States, the Micra TPS is an
investigational device and not yet approved for commercial use. The
device was awarded CE Mark in April 2015 based on earlier data from
the Medtronic Micra TPS Global Clinical Trial.
The trial enrolled 744 patients; it is ongoing and
will continue to evaluate the safety and efficacy of the device
through a single-arm, multi-center study at 56 centers in 19
countries. Primary endpoints of the trial were freedom from
device-related or procedure-related major complications with target
performance of >90 percent (lower CI >83 percent) at six
months, and low and stable pacing thresholds as demonstrated by
<= 2V and no increase of >1.5V (relative to implant) and
target performance of >89 percent (lower CI >80 percent) in
the first 300 patients at six months.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
Multimedia Release
A multimedia version of this release, with animation and
downloadable graphics can be found at: http://bit.ly/1KZCnLQ
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
Contacts:
Kathleen Janasz
Public Relations
+1-612-743-8995
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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